Atezolizumab Medicine 04 June 2024 Extended indication Extension of indication to include first-line treatment of adult patients with non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy and who do not have EGFR mutant or ALK-positive disease, who have: locally advanced unresectable NSCLC not amenable for definitive chemoradiotherapy, or metastatic NSCLC. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Atezolizumab Domain Oncology Reason of inclusion Indication extension IND Main indication Lung cancer Extended indication Extension of indication to include first-line treatment of adult patients with non-small cell lung cancer (NSCLC) who are ineligible for platinum-based chemotherapy and who do not have EGFR mutant or ALK-positive disease, who have: locally advanced unresectable NSCLC not amenable for definitive chemoradiotherapy, or metastatic NSCLC. Current proprietary name Already available biosimilars / generics Proprietary name Tecentriq Manufacturer Roche Portfolio holder Roche Mechanism of action PD-1 / PD-L1 inhibitor Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks An engineered anti-PD-L1 antibody. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date September 2023 Expected Registration September 2024 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT03191786 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 40,000.00 - 60,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Additional remarks Op basis van lijstprijs per vial (1.200 mg atezolizumab) van €4.145, Kosten per patiënt per jaar zijn een inschatting in verband met onbekende behandelduur. Voor alle indicaties van atezolizumab geldt een financieel arrangement die is voortgekomen uit de onderhandelingen in de sluis (lopend tot en met 31 december 2020). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks